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510(k) K041378

BIO 60 by Kodent, Inc. — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2004
Date Received
May 24, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

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  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
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  • K032321 — CERA F ALLOY (September 30, 2003)